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Recording

Oral Plenary Session II - Fellows Plenary and Late-Breaking

Oral Plenary Sessions

(16) Early amniotomy after Foley balloon in labor induction: a randomized clinical trial

Tuesday, February 13, 2024

9:45 AM – 10:00 AM

Location: Potomac Ballroom, Ballroom Level

Primary & Presenting Author(s)

Marissa J. Berry, MD (she/her/hers)

Maternal Fetal Medicine Fellow
The Ohio State University
Columbus, Ohio, United States

Coauthor(s)

KL

Kelly Lamiman, MD

University of Texas Medical Branch
Galveston, TX, United States
MS

Megan Slan, MD

McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth)
Houston, TX, United States
XZ

Xue Zhang, MD

University of Texas Medical Branch
Galveston, TX, United States
Daphne D. Arena Goncharov, MD

University of Texas Medical Branch
Galveston, TX, United States
YH

Yihharn P. Hwang, MD

Obstetrics and Gynecology Resident Physician
University of Texas Medical Branch
Galveston, TX, United States
JR

Jennifer Rogers, MD

University of Texas Medical Branch
Galveston, TX, United States
Luis D. Pacheco, MD

Professor
University of Texas Medical Branch
Friendswood, TX, United States
George R. Saade, MD (he/him/his)

Professor & Chair of Ob-Gyn
Eastern Virginia Medical School
Norfolk, VA, United States
Antonio F. Saad, MD (he/him/his)

Professor in Maternal Fetal Medicine and Critical Care
Inova Health
Fairfax, VA, United States

Objective: To investigate if early amniotomy (within two hours) post-Foley balloon expulsion shortens active labor and quickens vaginal delivery compared to amniotomy after greater than four hours.

Study Design: In a single-center, randomized trial of 150 participants undergoing labor induction with Foley balloon from October 2020 to March 2023, subjects were categorized into early or delayed amniotomy post-Foley balloon removal. Primary outcome: time between Foley balloon placement and active labor initiation. Secondary outcomes: time to delivery, rates of vaginal delivery within set intervals, cesarean section rates, maternal complications, and neonatal outcomes. Outcomes were analyzed both with intention-to-treat and per-protocol analyses.

Results:

149 out of 150 participants were analyzed. Protocol adherence was 90.7% of subjects in the early amniotomy group and 77% in the delayed amniotomy group. The most common reason for protocol non-adherence was spontaneous rupture of membranes. Both groups had comparable characteristics. Early amniotomy led to quicker progression to active labor (312.5 vs. 442.5 mins, P=0.02) and delivery (484 vs. 587 mins, P=0.03). Moreover, a higher proportion delivered within 36 hours (96% vs. 85%, P=0.03). The early group advanced to active labor and delivery 1.5 times faster post-Foley balloon placement (HR, 1.5; 95% CI, 1.1-2.2; P = 0.02). The delayed group had more cases of postpartum hemorrhage (0% vs. 9.5%, P=0.01), but other outcomes, like cesarean rates and maternal/neonatal outcomes, did not differ significantly.

In the per-protocol analysis, early amniotomy consistently resulted in quicker progression to active labor and delivery and higher delivery rates within specific timeframes. Postpartum hemorrhage was again more common with delayed amniotomy (0% vs. 8.8%, P=0.02).

Conclusion: Early amniotomy post-Foley balloon promotes faster active labor onset and time to delivery without increasing adverse outcomes. Additionally, it is associated with reduced postpartum hemorrhage risk.